Sr Manufacturing Engineer- Medical Device - Master compliance : Job Details

Job Title - Sr Manufacturing Engineer -Medical Device.

Job Location - Warsaw, Indiana (Fully On Site.)

Type - Contract ( W2 Only ).

Duration - 12 Months.

Expertise in CNC Machining

• Strong knowledge of CNC turning and CNC grinding technologies.

Problem Solving & Process Improvement

• Skilled in root cause analysis, formal problem-solving tools (e.g., CAPA, FMEA, Lean, Six Sigma).

Tooling & Equipment Design

• Experience designing fixtures, gages, cutting tools, and implementing process validations.

This role supports the development and optimization of manufacturing processes for machining, metal finishing, and assembly operations, ensuring quality, safety, and cost-effectiveness. The engineer will drive process improvements, support new product introductions (NPI), and collaborate cross-functionally with Quality, Operations, and Product Development.

• Develop and maintain manufacturing methods and process sheets.
• Troubleshoot and resolve technical production issues on the shop floor.
• Design and validate new tools, fixtures, gages, and machining setups.
• Lead or participate in FMEA, risk management, and design reviews.
• Ensure compliance with CAPA and change control processes.
• Optimize production layouts, equipment usage, and workflow.
• Support and execute validation protocols (IQ/OQ/PQ).
• Update CNC programs, BOMs, routings, and documentation in response to engineering changes.
• Drive continuous improvement for cost, quality, and delivery performance.